Disposable infusion device filling apparatus and method

ABSTRACT

An infusion system includes a disposable wearable infusion device and a filler device. The disposable infusion device has a body arranged to be adhered to a patient&#39;s skin and a reservoir for holding a liquid medicant to be infused into the patient. The filler device is arranged to detachably receive the infusion device body and to transfer a volume of the liquid medicant to the infusion device reservoir. The filler device may be part of a service device arranged to detachably receive the infusion device and which also includes a cannula driver and a cannula for providing the infusion device with a cannula and deploying the cannula to beneath a patient&#39;s skin.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patent Divisionalapplication Ser. No. 13/024,618, filed Feb. 10, 2011, which claimspriority to U.S. Non-Provisional application Ser. No. 11/604,166, filedNov. 22, 2006, allowed on May 10, 2011, all applications are hereinincorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

Tight control over the delivery of insulin in both type I diabetes(usually juvenile onset) and type II diabetes (usually late adultonset), has been shown to improve the quality of life as well as thegeneral health of these patients. Insulin delivery has been dominated bysubcutaneous injections of both long acting insulin to cover the basalneeds of the patient and by short acting insulin to compensate for mealsand snacks. Recently, the development of electronic, external insulininfusion pumps has allowed the continuous infusion of fast actinginsulin for the maintenance of the basal needs as well as thecompensatory doses (boluses) for meals and snacks. These infusionsystems have shown to improve control of blood glucose levels. However,they suffer the drawbacks of size, cost, and complexity. For example,these pumps are electronically controlled and must be programmed tosupply the desired amounts of basal and bolus insulin. This preventsmany patients from accepting this technology over the standardsubcutaneous injections.

Hence, there is a need in the art for a convenient form of insulintreatment which does not require significant programming or technicalskills to implement to service both basal and bolus needs. Preferably,such a treatment would be carried out by an infusion device that issimple to use and mechanically driven negating the need for batteriesand the like. It would also be preferable if the infusion device couldbe directly attached to the body and not require any electronics toprogram the delivery rates. The insulin is preferably delivered througha small, thin-walled tubing (cannula) through the skin into thesubcutaneous tissue similar to technologies in the prior art.

While the idea of such a simple insulin delivery device is compelling,many obstacles must be overcome before such a device may become apractical realty. One problem resides in insulin supply. Patients varygreatly on the amount of insulin such a device must carry to providetreatment over a fixed time period of, for example, three days. This isone environment where one size does not fit all. Another problem is withcannula deployment to support insulin delivery. Cannula deployment tosupport delivery of the insulin beneath the patient's skin must be madeeasy and convenient. This is not as easy as it seems because cannuladeployment, as generally and currently performed in the art, requiresinsertion of a cannula carrying needle into the patient and thenretraction of only the needle to leave the cannula in place beneath thepatient's skin. As will be seen subsequently, the present inventionaddresses these and other issues toward providing a simple, practical,and reliable insulin delivery device.

SUMMARY OF THE INVENTION

The invention provides an infusion system comprising a disposablewearable infusion device having a body arranged to be adhered to apatient's skin and a reservoir for holding a liquid medicant to beinfused into the patient. The system further comprises a filler devicearranged to detachably receive the infusion device body and transfer avolume of the liquid medicant to the infusion device reservoir.

The filler device may have a window through which the liquid medicantwithin the reservoir may be observed. This enables trapped air to beviewed and removed.

The filler device may have a cavity for receiving a vial of the liquidmedicant, and establishes fluid communication between the infusiondevice reservoir and the liquid medicant upon concurrently receiving theinfusion device body and the vial of liquid medicant. The filler devicemay arranged to transfer a desired volume of the liquid medicant fromthe vial to the infusion device reservoir. The filler may, for example,be arranged to meter a predetermined volume of medicant from the vial tothe reservoir.

The filler device is preferably enabled to transfer a volume of theliquid medicant to the infusion device reservoir upon the cavityreceiving the vial of the liquid medicant. The filler may furtherincludes a pump that transfers the liquid medicant from the vial to theinfusion device reservoir. The pump may be arranged to pump air into thevial to displace liquid medicant from the vial and into the reservoir.The filler may include a vent that vents the vial to atmosphericpressure when being received in the cavity. The filler cavity may sealthe vial after the vent vents the vial to atmosphere as the cavityreceives the vial.

The invention further provides a method comprising the steps ofproviding a disposable infusion device adapted to adhere to a patient'sskin and having a reservoir for holding a liquid medicant to be infusedinto the patient, filling the reservoir at least partially with theliquid medicant, adhering the device to the patient's skin, anddeploying a cannula through the device to beneath the skin of thepatient

The filling step may be performed before the adhering step is performed.The method may further include the step of pre-selecting a desiredamount of the liquid medicant to be filled into the reservoir beforefilling the reservoir. The filling step may comprise the further step ofdetachably joining the device to a filler and providing the filler witha vial of the liquid medicant. The filling step may further comprisepumping liquid medicant from the vial into the reservoir. The pumpingstep may comprise admitting air into the vial to force liquid medicantfrom the vial into the reservoir. The filling step may further compriseventing the vial to atmospheric pressure before admitting the air intothe vial. The filling step may include pre-selecting a desired amount ofair to be admitted into the vial before admitting the air into the vial.The method may further include the step of removing air trapped in thereservoir after the reservoir is filled with the liquid medicant.

The method may include the further step of detaching the infusion devicefrom the filler prior to adhering the device to the patient's skin. Thedeploying step may comprise detachably joining the infusion device to acannula driver containing the cannula and driving the cannula from thecannula driver through the infusion device. The method may still furtherinclude the step of detaching the cannula driver from the infusiondevice after the cannula is deployed.

The method may further comprise the step of detachably joining theinfusion device to a service device having a liquid medicant filler andthe cannula to be deployed. The filling step may then further includeinserting a vial of liquid medicant into the filling device from whichthe reservoir is to be filled. The adhering step may be performed withthe service device joined to the infusion device and the deploying stepmay comprise driving the cannula from the service device through theinfusion device. The service device may then be detached from theinfusion device after the cannula is deployed.

In another embodiment, an infusion system comprises a disposablewearable infusion device having a body arranged to be adhered to apatient's skin and a reservoir for holding a liquid medicant to beinfused into the patient, and a service device arranged to detachablyreceive the infusion device body. The service device has a filler thatprovides the infusion device reservoir with the liquid medicant and acannula driver including a cannula arranged to drive the cannula into adeployed position extending from the infusion device to beneath thepatient's skin.

In another embodiment, a filler device for filling a reservoir of adisposable wearable infusion device with a liquid medicant comprises abody arranged to detachably receive the infusion device and having acavity for receiving a vial of the liquid medicant, a conduit thatestablishes fluid communication between the infusion device reservoirand the liquid medicant, and a pump that transfers a volume of theliquid medicant from the vial to the infusion device reservoir.

In a further embodiment, a service device for use with a disposablewearable infusion device having a reservoir for holding a liquidmedicant to be infused into a patient comprises a body arranged todetachably receive the infusion device and having a cavity for receivinga vial of the liquid medicant, a filler that provides the infusiondevice reservoir with a volume of the liquid medicant from the vial, anda cannula driver including a cannula. The cannula driver is arranged todrive the cannula into a deployed position extending from the infusiondevice to beneath the patient's skin.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further features and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is a schematic representation of a reservoir within a disposablewearable diffusion device being filled with a liquid medicant accordingto an embodiment of the present invention;

FIG. 2 is perspective view of an infusion device embodying the presentinvention;

FIG. 3 is a perspective view of the device of FIG. 2 with the devicerotated 180 degrees;

FIG. 4 is a side view, with portions cut away, of a service deviceembodying the present invention with an infusion device detachablyreceived therein and about to receive a vial of liquid medicant;

FIG. 5 is side view, with portions cut away, of the service device ofFIG. 4 after having partially received the vial of liquid medicant forventing the interior of the vial to atmospheric pressure in accordancewith an embodiment of the present invention;

FIG. 6 is a side view, with portions cut away, of the service device ofFIG. 4 after having fully received the vial of liquid medicant toestablish fluid communication between the vial and the infusion devicein accordance with an embodiment of the present invention;

FIG. 7 is a side view, with portions cut away, of the service device ofFIG. 4 after having provided the infusion device with a desired quantityof the liquid medicant from the vial;

FIG. 8 is a side view, with portions cut away, of the service device ofFIG. 4 after having been placed in a cannula drive configuration to anenable a cannula driver in accordance with an embodiment of the presentinvention;

FIG. 9 is a side view, with portions cut away, of the service device ofFIG. 4 after the cannula driver has driven a cannula carried on an innerneedle to a cannula deployment position;

FIG. 10 is a side view, with portions cut away, of the service device ofFIG. 4 after the cannula driver has withdrawn the needle upon which thecannula was driven from the cannula leaving the cannula behind in adeployed position; and

FIG. 11 is a side view, with portions cut away, of the service device ofFIG. 4 after the infusion device and the service device are separatedleaving the infusion device deployed on the skin of the patient with thecannula extending beneath the patient's skin in a deployed position todeliver the liquid medicant to the patient.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, it is a schematic representation of an infusionsystem embodying the present invention. The system 100 generallyincludes a disposable wearable infusion device 110 and a filler 130. Thefiller 130 is seen in FIG. 1. filling a reservoir 112 within thediffusion device 110 with a measured quantity of a liquid medicant, suchinsulin, for example, according to an embodiment of the presentinvention.

The device 110 includes a body or enclosure 120 that is adhered to theskin 140 of a patient and that encloses the reservoir 112. The device130 further includes a cannula 124 deployed from the device 110 tobeneath the skin 140 of a patient to deliver the liquid medicant. Thereservoir 112 is coupled to the cannula 124 by a pump 114 and a one-waycheck valve 116. Actuation of the pump provides a fixed quantity of themedicant to the cannula.

The filler 130 is adapted to receive a vial 132 of the liquid medicant133. A first conduit 136 provides fluid communication from the vial 132,through a filling port septum 126, and into the reservoir 112. A secondconduit 138 provides fluid communication from a pump 135 to the vial.The pump 135 is employed to pump air into the vial 132 to displace aknown quantity of the liquid medicant 133 from the vial 132. Themedicant is then delivered to the reservoir through the first conduit136. As will be seen subsequently, and in accordance with one aspect ofthe present invention, as the vial 132 is received by the filler 130,the interior space 134 within the vial 132 is vented to atmosphericpressure and then sealed. This venting of the vial 132 assures that aknown volume of air being pumped into the vial will displace a likevolume of medicant for filling the reservoir.

Once the reservoir 112 is filled with a desired quantity of liquidmedicant, the infusion device may be adhered to the patient's skin 140.Preferably thereafter, the cannula 124 is deployed.

Referring now to FIG. 2, it is perspective view of an infusion device210 embodying the present invention. FIG. 3 is a perspective view of thedevice 210 after being rotated 180 degrees. The device 210 includes anenclosure 220 and a base 222. The device 210 further includes a pair ofactuator buttons 214 and 216 which, when concurrently depressed, cause afixed quantity of liquid medicant to be dispensed from a cannula 224.The device 210 further includes a filler port septum 226 through whichthe reservoir (not shown) is filled and a viewing window 227 throughwhich the liquid medicant may be viewed during the filling process. Moreparticularly, the viewing window provides a means by which air bubbleswithin the reservoir may be seen to facilitate removal thereof. Lastly,as may be seen in FIGS. 2 and 3, the device 210 includes an auxiliaryport septum 228. The port septum 228 is provided to enable deployment ofthe cannula 224 in a manner as described subsequently and to receiveboluses of liquid medicant, such as basal or long acting insulin, to bedispensed through the cannula 224.

FIG. 4 is a side view, with portions cut away, of a service device 300embodying the present invention with the infusion device 210 detachablyreceived therein. The service device includes a filler device 330 and acannula driver 360. The filler device 330 and cannula driver 360, forreasons which will become apparent herein after, are pivotally connectedat a pivot point 400.

As seen in FIG. 4, the filler device 330 is about to receive a vial 132of liquid medicant. The filler device 330 includes a cavity 332 forreceiving the vial 132. The filler device 330 further includes a firstconduit 336 and a second conduit 338. As described in connection withFIG. 1, the first conduit 336 serves to provide fluid communicationbetween the vial 132 and the reservoir (not shown) of the infusiondevice 210 to be filled. The second conduit 338 provides fluidcommunication between the pump 335 within the filler device 330 and thevial 132. The first conduit 336 is carried on a stop 337 which is springloaded by a spring 339. As will be seen subsequently, when the vial 132engages stop 339, further movement of the vial into the cavity 332 willcause the first conduit 336 to travel with the stop 339 and vial 132forcing the end of the first conduit 336 into the filling port septum226.

The filler device 330 also includes an interlock 340 that prevents thepump arm from being displaced and thus premature actuation thereofbefore the vial 132 is fully received within the cavity. Hence, thefiller device is enabled to transfer a volume of the liquid medicant tothe infusion device reservoir only upon the cavity 332 fully receivingthe vial 132. To that in end, the interlock 340 includes a follower 342and an inter-connected latch 344. As shown in FIG. 4, the latch 344prevents the arm 341 from being displaced. However, when the vial isreceived into the cavity 332, the follower engages the vial 132 and isdisplaced causing the latch to be pulled free of the arm 341. Thisoperation will be seen more clearly herein after.

FIG. 5 shows how the vial 132 may be vented as it is received into thecavity of the filler device 330. In FIG. 5 it may be seen that the vial132 has a sealing membrane 137. Also, it may be seen that the firstconduit 226 includes an opening 345 displaced from the end 347 of thefirst conduit 336. To vent the vial 132, the vial 132 and the fillerdevice 330 are inverted as illustrated. When the vial 132 is advanced tocause the membrane to be pierced by the end 347 of the first conduit336, the vial 132 is vented to atmospheric pressure as long as themembrane 137 is between the end 347 and the opening 345 of the firstconduit 336.

FIG. 6 shows the vial 132 fully received within the cavity 332 of thefiller device 330. The follower 342 has been displaced by its engagementwith the vial 132 to cause the latch 344 to be moved clear of the arm341. Also, the first conduit 336 has entered the filling port septum 226of the infusion device 210 after having traveled with the stop 337 andthe vial 132. The infusion device 210 is now ready to be filled with aquantity of liquid medicant from the vial 132.

FIG. 7 shows the filler device 330 after having filled the infusiondevice 210 with a quantity of liquid medicant. The quantity of liquidmedicant filled depends upon the length of travel of the arm 341 andhence the amount of air pumped into the vial 132 by the pump 335. Inthis manner, the quantity of liquid medicant filled may be accuratelypreselected and metered. Further, after the liquid medicant has beentransferred to the infusion device 210, the medicant may be viewedthrough the window 227 (FIGS. 2 and 3) for air bubbles. Any observed airbubbles may be eliminated by dithering the arm 341 back and forth. Thisdithering of arm 341 will cause air trapped in the reservoir to bereturned to the vial 132 and then returned to the reservoir. The amountof air returned to the reservoir each time is less than the amount ofair previously removed from the reservoir. Hence, in this manner, theair trapped in the reservoir may be removed.

After the filling process is completed, the vial 132 may be removed fromthe service device 300. Then, the cannula driver 360 is pivoted aboutpivot point 400 in the direction of arrow 350 (FIG. 7) and locked in theposition shown in FIG. 8. With the cannula driver 360 locked in theposition shown in FIG. 8, it is now in a cannula drive configuration.This results in a cannula/needle assembly 324 to be aligned with theauxiliary port septum 228 of the infusion device 210. The base 222 ofthe infusion device 210 may now be adhered to the patient's skin.

As will be seen subsequently, a first drive element 362 may now bereleased to drive the cannula/needle assembly 324 through the portseptum 228 rendering the cannula 224 in a deployed position (FIG. 9) Asecond drive element 366 may thereafter be released to withdraw only theneedle 225 back into the driver 360 leaving the cannula 224 in itsdeployed position and the needle safely tucked away for sharps disposal.

With further reference to FIG. 8, the first drive element comprises aspring. The spring 362 is coupled to a follower 364. The spring 362 maybe released by the concurrent depression of a pair of aligned actuatorbuttons on opposite sides of the driver 360. One such actuator button370 is shown in the FIG. 8. Preferably the actuator buttons are onlycoupled to release the springs 362 and 366 when the driver 360 is lockedin the cannula drive configuration. Hence, in this manner, the driver isenabled only when the driver is properly positioned and locked for thepurpose of deploying the cannula 224.

FIG. 9 shows the driver 360 after the cannula/needle assemble 324 havebeen driven through the port septum 228 and the infusion device 210 tobeneath the patient's skin 140. It will be noted that the first spring362 has been released and that the follower 364 is at the end of itstravel. The second spring 366 may now be released to withdraw the needle225 from the cannula 224.

FIG. 10 shows the driver 360 after the needle has been withdrawn fromthe cannula 224. The needle 225 has been withdrawn back out of theinfusion device 210, through the port septum 228, and into a cavity 372within the driver 360. Hence, it will be noted that the second spring366 has been released and that the follower 368 is at the end of itstravel. With the needle 225 withdrawn from the cannula 224, the cannula224 is left in its deployed position beneath the skin 140 of the patientwhile the needle 225 is safely stored in cavity 372 for sharps disposal.

Now that the cannula 224 is deployed, the service device 300 may beremoved from the infusion device 210. This is illustrated in FIG. 11.The service device 210 has been removed and separated from the infusiondevice 210. The infusion device 210 remains adhered to the patient'sskin 140 for delivering the liquid medicant, such as insulin, to thepatient through the cannula 224. The service device 300 may be thrownaway.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention as defined bythose claims.

What is claimed:
 1. An infusion system comprising: a disposable wearableinfusion device having a body arranged to be adhered to a patients skin,a port, and a reservoir for holding a liquid medicant to be infused intothe patient; and a filler device comprising a conduit for releasableattachment to the infusion device port, a cavity for receiving a vial ofliquid medicant, a displaceable arm, and a pump for pumping an amount ofair into the vial to displace from the vial a like amount of liquidmedicant, wherein the quantity of air pumped into the vial depends on alength of travel of the displaceable arm.
 2. The system of claim 1wherein the infusion device includes a window through which the liquidmedicant within the reservoir may be viewed.
 3. The system of claim 1,wherein the filler device establishes fluid communication between theinfusion device reservoir and the liquid medicant upon concurrentlyreceiving the infusion device body and the vial of liquid medicant. 4.The system of claim 3, wherein the filler device is enabled to transfera volume of the liquid medicant to the infusion device reservoir uponthe cavity receiving the vial of the liquid medicant.
 5. A filler devicefor filling a reservoir of a disposable wearable infusion device with aliquid medicant, comprising: a body; a cavity for receiving a vial ofthe liquid medicant; a conduit for releasable attachment to a port ofthe infusion device and that establishes fluid communication between theinfusion device reservoir and the liquid medicant; a displaceable arm;and a pump for pumping an amount of air into the vial to displace fromthe vial a like amount of liquid medicant to the infusion devicereservoir.
 6. The device of claim 5, wherein the pump is enabled totransfer the volume of the liquid medicant to the infusion devicereservoir upon the cavity receiving the vial of the liquid medicant. 7.The device of claim 5, wherein the conduit establishes fluidcommunication between the infusion device reservoir and the liquidmedicant upon the device concurrently receiving the infusion device andthe vial of liquid medicant.